跳至主要内容
临床试验/NCT06510933
NCT06510933招募中不适用

Stability Effects After Heel Cups Orthopedics Treatment in Different BMI Index and Its Correlation to Physical Activity in Children. A Longitudinal Intervention Study

Universidad Miguel Hernandez de Elche2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
2
主要终点
Stabilometry

研究概览

简要总结

Actual research relates Body mass Index (BMI) with postural changes in children and musculoskeletal disorders during growing period. BMI is widely used by clinicians and researchers due to easily capacity of application and scale classification patients in relation to their weight, the scale presents underweight, normal weight, overweight and obesity stages.

In paediatric context, underweight or overweight body mass in children negatively influences their posture, even in his adult life. Children with overweight and obesity shows less stability, and develop worse postural control, one of the demonstrated effects are the column alignment alteration and other bones structures. Elevated BMI are related to high differences in postural control, to elevated risk of pain, hypertension and musculoskeletal disorders. Underweight BMI is associated to less muscular mass and fat body composition, that are necessary to a correct posture, and contributes to increase probability of injuries.

The maintaining balance engages three systems, i.e., the vestibular system, vision, and proprioception. Some authors consider that postural stability develops between the ages 8 to 9. There are also papers arguing that the locomotor and postural model in 7-year-olds is similar to adults. Nevertheless, with new experiences and skills, it is possible to continue the development of all elements engaged in postural control, and keeping correct posture in children up to the age of 12 A good balance level and postural control is important in sport practice, to get high competition level efficiency in daily activities, and of course, in the clinic practice and rehabilitation.

Because of a stability loss off overweight in children, limited physical activity is established Posterior calf musculature and ankle has been shown to be involved in postural control in different studies. Likewise, the practice of physical activity induces changes in the infantile triceps suralis that generates improvements in postural control.

Currently, there are different paediatric pathologies for which heel cushions are prescribed as a treatment, such as Sever's disease leg, length discrepancy, relaxing and lenghtened calf muscles, but there is no evidence of stability effect of this treatment.

详细描述

A prospective intervention study was conducted in children before and after the application of heel cushions as a treatment for calf muscle retraction in various BMI conditions in children.

The design and progression of participants through the trial was conducted in accordance with the 22 CONSORT criteria.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 8-12 years old
  • Regular sports practice
  • Decreased range of flexión

排除标准

  • Having neurological, vestibular, muscular, psychological or visual visual disease.
  • Traumatic pathology 12 months prior to the measurement (sprains, talalgias, etc.).
  • Diseases of balance or motor control.
  • Surgeries in the last 12 months.
  • Taking medications that may affect the neuromuscular system.
  • Sports practice in the last 48 hours.

结局指标

主要结局

Stabilometry

时间窗: pre intervention, 3 months post intervention, 6 months post intervention

The measurements were conducted in the primary school of participating schools at a temperature of 22 ◦C, in the same hour of the day. To assess participants' balance, the anthropometric position of the protocol proposed by the International Society for the Advancement of Cineatropometry (ISAK) was assigned: participants placed their mi Frankfort; the upper limbs remained relaxed throughout the body, with palms facing forward and thumbs separated from the rest of the toes, and were barefoot with feet externally rotated f 30 degrees and with a heel distance of 4cm. The children were wearing sports costumes to contribute their free movement. For stabilometry data collection will use an inertial measurement instrument called Gyko® It is a state-of-the-art device that allows to measure an objective assessment of acceleration, angular velocity and with an acquisition frequency of 100Hz

heel cups in muscle retraction

时间窗: Pre intervention, 3 months post intervention, 6 months post intervention.

Orthopaedic treatment of calf muscle retraction is defined as heel cup. A 5mm heel cup height was applied. Made of ethyl vinyl acetate material with a hard shore A 65º. The main function of a heel pad was to provide a slight change in heel elevation

次要结局

  • Lunge test(Pre intervention, 3 months post intervention, 6 months post intervention.)
  • Physical Activity Questionnaire for Children (PAQ-C)(Pre intervention, 3 months post intervention, 6 months post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vicenta Martínez Córcoles

Principal Investigator PhD

Universidad Miguel Hernandez de Elche

研究点 (2)

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